Bioequivalence and Bioavailability Forum

Modelling [Design Issues]

posted by mittyri – Russia, 2020-02-04 09:02  – Posting: # 21140
Views: 681

Hi Helmut,

» » B) Capture day 1 PK from time 0 to end of dosing interval, repeat dosing for x # of days (base on dosing interval) to hit SS. On last day of dosing capture time 0 - x (x = whatever hrs needed to fully capture the elimination phase + half-life).
»
» To characterize the PK of a new drug by PK modeling you would always go with this approach and sample as long as possible. Funky things may happen in nonlinear PK (auto-induction / -inhibition, capacity-limited elimination, …)

I don't think the proposed scheme is good enough for modelling such difficult things. There are no Ctau's planned. Moreover, I would mix the A and B for that purpose.

And sorry for a broken link, I cannot carve in my mind that tags for years

Complete thread:

• Study which captures SD and SS PK Profiles jag009 2020-02-03 20:15 [Design Issues] 
  • A vs B mittyri 2020-02-03 21:05
    • A vs B jag009 2020-02-03 21:29
  • ANDA or NDA? Helmut 2020-02-04 00:57
    • Modellingmittyri 2020-02-04 09:02
      • Modelling Helmut 2020-02-04 12:17
        • Modelling: SD+SS mittyri 2020-02-04 12:38